June’s Regulatory Focus: Nutrition in health and disease management, and the gut microbiome

This issue marks the 6th annual RAPS series on nutrition in health and disease management, and the gut microbiome, in which global experts write about food, nutrition, and dietary supplements from regulatory, trade, marketing, and legal perspectives. In keeping with the series, articles in the current issue examine US Food and Drug Administration (FDA) regulatory guidance and requirements, especially regarding dietary supplements, bioengineered products, probiotics, and COVID-19; harmonization of retail and technical standards; and global regulation of CDB use in food and food supplements. Also included were articles on compliance with the EU In Vitro Diagnostic Regulation (IVDR) in a small organization and preparing for the transition to the International Council for Harmonisation’s (ICH) M10 guidance.
 

FDA regulations and guidance

Nearly 3 years have passed since the FDA issued its draft guidance for industry on the labeling of probiotic quantity. During that time, consumer interest in probiotics has increased, product innovation has expanded, and the body of scientific research has grown – but federal regulatory action on probiotics has stalled. In Best practices and education for probiotics amid regulatory uncertainty, Andrea W. Wong describes how the Council for Responsible Nutrition (CRN) and the International Probiotics Association (IPA) have developed scientifically based best practices for the labeling, storing, and stability testing of dietary supplements containing probiotics to facilitate transparency and consistency in the probiotic sector.
 
FDA observations for adulterated dietary supplements have remained consistent since 2010, even amid the COVID-19 pandemic. However, an increase in the number of misbranded dietary supplements also was observed during the pandemic, prompting FDA to use updated, alternative, and remote enforcement tools to ensure compliance. In Current status and future FDA enforcement of dietary supplements, Tara Lin Couch outlines current good manufacturing practice (cGMP) and the pandemic-related changes to requirements for facility inspections, serious adverse effects reporting, and foreign supplier verification. Her suggestions for the industry to improve compliance include establishing specifications and follow-up testing to determine the specifications have been met and ensuring the responsibilities of the quality unit are defined in written processes and executed as evidenced in records.
 
In Disclosure under the national BE standard for dietary supplements, Karin Moore and Ricardo Carvajal  review the requirements for disclosure under the National Bioengineered Food Disclosure Standard (BE standard). The authors note manufacturers and importers of dietary supplements should be focused on developing strategies for compliance and evaluating each product’s BE status in advance of the mandatory compliance deadline on 1 January 2022. They caution that the process may require detailed communications and cooperation among different entities in the supply chain and could result in revisions in existing manufacturing and supply agreements.
 
In ‘Immune’ claims and COVID-19, Katie Bond and Brian Fries review the federal and state enforcement, self-regulatory actions, and class actions that are reshaping the landscape for foods and dietary supplements marketed for the immune system, especially in context of the COVID-19 pandemic. They caution that regulators are scrutinizing the product category and taking action and that companies need to be aware of the enforcement and other challenges and avoid the same pitfalls. Some takeaways for for low-risk claims include avoiding claims, imagery, or other elements that reference any disease and confirming that all claims can be substantiated.
 

Harmonization and CBD regulation

On the topic of harmonization, Alicia AJ Ng documents the 17-year journey of the Association of Southeast Asian Nations (ASEAN) Agreement on Regulatory Framework for Health Supplements. The Agreement is a major first step forward in enabling regulatory submissions and reviews of health supplements in the ASEAN region and will be signed into effect at the end of 2021. In The ASEAN harmonization of technical standards on health supplements – An industry perspective, Ng outlines the regulatory context and history to the Agreement as well as the processes and advantages and challenges of harmonizing the technical standards. She highlights the importance of continued nurturing of public-private partnerships and industry involvement and full implementation of the Agreement if the participants are to benefit meaningfully from the harmonization efforts.
 
In Global regulatory trends in CBD use in food and food supplements, David Pineda Ereño assesses current regulatory complexities in realizing commercial opportunities and the challenges and opportunities for bringing food and food supplement products containing CBD to markets in different regions and countries. Pineda Ereño notes companies should keep current with this evolving regulatory environment to develop successful marketing strategies and identify upcoming business opportunities.
 

IVDR and ICH M10

Also included in this month’s line-up are two articles on the IVDR and ICH’s M10 guidance support for the transition to a more harmonized drug development industry. In EU IVDR compliance in a small organization, Anali Peralta and Murtuza Bohari provide a user-friendly, step-by-step guide for small organizations on how to comply with the regulation. In The transition to ICH M10 and its impact on global submissions, Tom Zhang and Colton Wong examines the key elements of the M10 standard and recommend strategies for successful new drug or clinical trial applications.
 

Upcoming in Regulatory Focus

What’s coming in July?
Articles during July will examine Real-World Evidence and Data. Look for this topic and more throughout July at Regulatory Focus.
 
And August?
For the August issue, Regulatory Focus will examine Alternative Regulatory Pathways. The submission due date for articles is 30 July 2021. To contribute, email rmatthews@raps.org.
 
September monthly issue: Call for articles
In September, Regulatory Focus will cover Diversity in Regulatory Affairs. The submission due date for articles is 1 August 2021. To contribute, email rmatthews@raps.org.
 

Upcoming in RF Quarterly

Regulatory Focus launched the inaugural issue of RF Quarterly in mid-March, and the summer issue, focusing on artificial intelligence, is now available.
 
Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit. The themes for the rest of 2021 will be:

• Quality and Compliance in Regulatory Affairs (September)
• RAPS 2021 Convergence (December)

 
To contribute to the September issue of RF Quarterly, email rmatthews@raps.org.
 
For more information, see Guidelines for Authors and the 2021 Editorial Calendar.